Nocturnal Insulin-Glucose in Hospital: Tight Control

Not Applicable

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT02160184
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

The aim of the study is to assess the efficacy and safety of a closed-loop system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS) in patients with type 1 diabetes for controlling the nocturnal and post-breakfast periods. Intervention will be to apply the automated closed-loop system by administering a subcutaneous insulin microbolus every 5 minutes depending on reading from a continuous glucose measurement (CGM) system.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Status Verified: 2014-06
• Study First Submitted: 2014-06-09
• Study First Submitted QC: 2014-06-09
• Study First Posted: 2014-06-10
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Type 1 Diabetes
• Diabetes duration > 3 years
• Continuous Subcutaneous Insulin Infusion (CSII) treatment for more than 1 year
• A1c 6-9%
• No ketoacidosis during the previous 12 months
• Glomerular Filtration Rate (GFR) > 60 ml/kg/min m2
• Willingness of participate and signed and dated written informed consent in accordance with Good Clinical Practice

Exclusion Criteria

• Gastroparesis
• Hypoglycemia unawareness
• Uncorrected visual impairment
• Deafness
• BMI> 35 kg/m2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of time in target range (3.9-8.0 mmol/l) YSI glucose during the in clinic overnight visit.	During the closed-loop period for each patient: 12 hours

Trial Locations

Locations (1)

Parc Tauli University Hospital; 🇪🇸 Sabadell, Barcelona, Spain